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WO1996003104A1 - Procede et dispositif de traitement des maladies osseuses - Google Patents

Procede et dispositif de traitement des maladies osseuses Download PDF

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Publication number
WO1996003104A1
WO1996003104A1 PCT/US1994/008544 US9408544W WO9603104A1 WO 1996003104 A1 WO1996003104 A1 WO 1996003104A1 US 9408544 W US9408544 W US 9408544W WO 9603104 A1 WO9603104 A1 WO 9603104A1
Authority
WO
WIPO (PCT)
Prior art keywords
patient
bone
rate
impulse
prescribed
Prior art date
Application number
PCT/US1994/008544
Other languages
English (en)
Inventor
C. Andrew L. Bassett
Govert L. Bassett
Original Assignee
Osteo-Dyne, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to US08/085,300 priority Critical patent/US5484388A/en
Application filed by Osteo-Dyne, Inc. filed Critical Osteo-Dyne, Inc.
Priority to PCT/US1994/008544 priority patent/WO1996003104A1/fr
Priority to AU75169/94A priority patent/AU7516994A/en
Publication of WO1996003104A1 publication Critical patent/WO1996003104A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H1/00—Apparatus for passive exercising; Vibrating apparatus; Chiropractic devices, e.g. body impacting devices, external devices for briefly extending or aligning unbroken bones
    • A61H1/006—Apparatus for applying pressure or blows for compressive stressing of a part of the skeletal structure, e.g. for preventing or alleviating osteoporosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H1/00—Apparatus for passive exercising; Vibrating apparatus; Chiropractic devices, e.g. body impacting devices, external devices for briefly extending or aligning unbroken bones
    • A61H1/005—Moveable platforms, e.g. vibrating or oscillating platforms for standing, sitting, laying or leaning
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2203/00—Additional characteristics concerning the patient
    • A61H2203/04—Position of the patient
    • A61H2203/0406—Standing on the feet

Definitions

  • the present invention relates generally to the treatment of osteoporosis and afflictions characterized by inadequate local or general bone mass, and specifically the use of impact loading of bone under a gravitational or mechanically-induced preload.
  • Osteoporosis is a pernicious disorder usually, but not exclusively, afflicting elderly women.
  • the osteoporotic state can also be manifest by those who are confined to bed and even by astronauts who are in a weightless environment. Osteoporosis occurs through a decrease in bone mass which makes the afflicted bones more fragile and more susceptible to breaking.
  • osteoporosis can cause death, require extended hospital stays, and sometimes involve expensive and painful surgery. Health care costs for this condition approach ten billion dollars per year in the U.S. alone. In addition, osteoporosis severely diminishes the mobility and vitality of those affected with the disease.
  • Wolff's law states, in short, that bone adapts to the forces acting upon it. In other words, bone will increase in mass and remodel to relieve the applied stress.
  • bone is piezoelectric and electrokinetic, it generates an electrical signal in response to the applied force. That electrical signal then effects bone formation. This is explained in Bassett, "Effect of Force on Skeletal Tissues," Physiological Basis of Rehabilitation Medicine, Downey and Darling eds., 1st ed., W. B. Saunders Co. (1971). On the basis of Wolff's law and more recent investigations, two techniques have been developed for treatment of bone disorders. One involves mechanical forces and the other involves electrical forces.
  • the method preload the bone in a selected direction and then apply a series of impulses to the patient in the same direction.
  • the patient can also be maintained in a static position, especially if gravity provides the preloading.
  • a method of treating a bone in a patient comprises the steps of maintaining the patient in a static position, preloading the bone in a first direction, and applying to the bone in the first direction a series of impulses.
  • the first direction is determined according to the patient's skeletal tissue, and the characteristics of the series of impulses are determined according to the patient's skeletal tissue such that the impulses deliver to the bone a prescribed impact load at a prescribed impact rate.
  • the prescribed impact load and prescribed rate are chosen to generate electrical signals in the patient's bone such that the majority of energy of the electrical signals lies between 0.1 Hz and 1 kHz, and the peak amplitude values of the electrical signals lie between 15 and 30 Hz.
  • Preloading can be provided through compression of the bone.
  • Figure 1 is a drawing of a patient on a device in accordance with the prescribed invention.
  • Figure 2 is a cutaway side elevation of the platform of Figure 1.
  • Figures 3(a) and 3(b) are views of two devices for providing mechanical preloading of the bone.
  • Figure 4 shows mechanical compression of a forearm and an impact generator according to an embodiment of the invention.
  • Figure 5 shows a microcomputer and associated hardware for updating and reading information on a patient data module.
  • Figure 1 shows a patient 5 on a platform 10 containing a mechanism for generating an impact.
  • a back rest 15 with a pad 16 stabilizes the patient and helps the patient assume an erect posture which will maximize transmission of the impulse from the heels up through the legs and spine.
  • the preferred posture includes locked knees combined with a forwardly thrusted pelvis, a slightly arched back, and thrown-back shoulders.
  • Back rest 15 is vertically adjustable.
  • the preferred height for pad 16 is in the small of patient 5's back.
  • the horizontal displacement of pad 16 should be set to allow patients to lean backwards slightly during treatment.
  • the device of this invention functions efficiently by ensuring that the bone under treatment is subject to a preload. If the femoral neck and spine are the bones being treated, the patient is kept upright so that gravity produces loads of 500-1000 microstrains in these structures before impact. The impact loads are additive to the preload which greatly increases their efficiency.
  • dual impulse translators may be used to apply differing treatments to the left and right legs.
  • Platform 10 and its components are shown in greater detail in Figure 2.
  • solenoid 12 and translator 14 provide the selected impact.
  • Solenoid 12 is alternately energized and de-energized to move against retraction spring 18 and strike a bellcrank 13. This striking causes bellcrank 13 to rotate about pivot 17 to provide a vertical force to impulse translator 14.
  • Any appropriate device which can repeatedly strike impulse translator 14 can be used to generate impacts.
  • Dual impact generators and impact translators may be provided so as to allow differing treatment of the left and right legs.
  • Possible devices include solenoids, linear actuators, air and hydraulic cylinders, high rise motor driven cams and torsion springs which are wound by similar engines.
  • levers and bellcranks may be used to modify their force and stroke characteristics or to change the direction of their stroke.
  • impulse translator 14 When struck, impulse translator 14 then imparts the suitable impulse to patient 5's heels.
  • Impulse translator 14 is a passive device which functions to modify impact energy so as to insure the resulting skeletal impulse load and load rate generate electrical signals in the patient's skeletal tissue such that the majority of generated energy lies between 0.1 Hz and 1 kHz with peak energy centered at approximately 15-30 Hz.
  • the velocity and forces developed by the solenoid 12 can be controlled with a servo- positioned stop 19 to limit its excursion.
  • the field strength and dwell-time of the solenoid 12 can also be changed to affect the frequency content. Additionally, cross-sectional and material properties of the translator 14 can play a role in determining high frequency responses in the impact. A more compliant translator will lower the frequency content of the impulse and a thicker, stiffer member will produce a higher frequency response. These frequencies have been shown to be more efficient in promoting osteogenesis and are chosen so as to reduce the amplitude of the impulse which must be delivered.
  • This direction, or vector should be the same as the preload, or independent compressive load, applied to the bone.
  • Vectoring of the preloading may be accomplished though modification of the patient stance. The purpose centers on altering stress distribution in the inferior medial femoral neck. These changes will modify the site-specific bone forming and resorbing responses on this anatomical position to gain the widest distribution and mechanical advantage of the increasing bone mass.
  • impulse translator 14 preferably includes a sensor 20 to measure impulse load and a sensor 21 to measure impulse rate. These measurements are transmitted to an A-to-D converter 30 which places the measurements in digital form for microprocessor 40.
  • A-to-D converter 30 which places the measurements in digital form for microprocessor 40.
  • Many commonly available sensing devices can be used to sense the impulse load and impulse rate. Load cells, strain gauges, piezoelectric devices, and accelerometers are just a few possible sensing devices.
  • Microprocessor 40 receives such signals to ensure that patient 5 is receiving the proper treatment.
  • Proper treatment is defined in terms of certain treatment parameters, such as the amount of preload to apply to the bone under treatment, the vectoring (i.e., angle) of the preload, the rate of impact, and the duration of treatment.
  • Patient 5's physician determines values for treatment parameters based upon an examination of the anatomical and structural characteristics of the patient's skeletal tissue, as well as upon factors such as the patient's weight and bone mineral density.
  • the patient's skeletal characteristics may be determined by common methods such as dual photon absorptiometry examination.
  • the physician may also consider the bone under treatment in determining values for treatment parameters.
  • the femoral neck length, cross-sectional moment of inertia and its angle to the vertical are important factors for determining the vector of the preload and treatment.
  • the strength of the femur depends primarily on proper anatomical distribution of bone tissue, particularly in the femoral neck which must carry a cantilevered load.
  • sample basic data now exists from the work of McLeod and Rubin to show very precise spatial distributions on bone being directed by the position of the extremity during gait. The purpose of this is to increase the strength of the femoral neck and thereby reduce its likelihood of breakage.
  • the purpose is to create impulses which causes the skeletal tissue under treatment to generate certain electrical signals.
  • those signals have a majority of energy between 0.1 Hz and 1 kHz, with the peak energy centered at approximately 15-30 Hz.
  • platform 10 The operation of platform 10 is initiated by inserting patient data module 51 into receptacle 53 in platform 10.
  • Data module 51 is preferably a disk or other programmable device for permanently storing data
  • receptacle 53 is preferably a connector, such as a receptacle, to allow data to be read from module 51.
  • Receptacle 53 is coupled to microprocessor 40 to enable microprocessor 40 to read the treatment parameters from module 51 into memory unit 41, which is also coupled to microprocessor 40.
  • Microprocessor 40 then reads the prescribed impact load, and impact rate to initiate treatment.
  • Microprocessor 40 controls the impact load delivered by the solenoid 12 by altering its stroke, voltage supply, current supply, or duration of energy supply through solenoid drive 42.
  • Microprocessor 40 controls the impact rate by controlling the rate of commands to solenoid 12 though solenoid drive 42.
  • Microprocessor 40 can monitor the treatment delivered to patient 5 by comparing the measured impulse load from sensor 20 and the measured impulse rate from sensor 21, with the prescribed impact load and prescribed impact rate, respectively, stored in memory unit 41. Microprocessor 40 can then modify the operation of solenoid 12 to match the prescribed impact load. Preferably, microprocessor 40 performs such modifications by sending commands to reduce any differences between measured and prescribed loads and the measured and prescribed rates.
  • microprocessor 40's comparison may also be used to generate audible and visual information to the patient via display 50. This is especially important when, as described below, patient 5 is responsible for reading the impact load and rate.
  • Display 50 gives the patient feedback to ensure that the proper impulse is being provided. Preferably, one display indicates the treatment is proper, another indicates that the treatment values are too low, and another indicates the values are too high.
  • patient data read into memory 41 from module 51 can the include duration which the microprocessor 40 uses to determine the number of impulses for a complete treatment session. After the required number of impacts, microprocessor 40 would stop solenoid 12. If duration is not provided, the treatment must be stopped manually, such as by a switch (not shown) .
  • microprocessor 40 places data it has collected from the treatment onto patient data module 51.
  • data preferably includes the measured impulse loads and impulse rates.
  • Another embodiment of this invention involves application of the principle of impact stimulation of osteogenesis to skeletal members other than the legs and spine.
  • the example chosen is the forearm as illustrated in Figures 3(a), 3(b), and 4.
  • the device 70 as illustrated in Figure 3(b), stabilizes the wrist.
  • a device 77 as illustrated in Figure 3(a), preloads the forearm by applying a compressive load to the fist and elbow and attaches to impact generator 71 and impulse translator 72.
  • Impulse translator 72 contains sensor 73 for measuring the impulse load and sensor 74 for measuring the impulse rate.
  • the impact generator 71, impulse load sensor 73 and impulse rate sensor 74 measuring means are connected to electronics similar to those in platform 10 of Figures 1 and 2 via cable 75.
  • Impact generator 71 repeatedly delivers an impact to impulse translator 72 which in turn delivers an impulse to the skeletal tissue through the elbow.
  • the impulses are measured by the impulse load sensor 73 and impulse rate sensor 74.
  • microprocessor 40 which compares the measurements with the prescribed values contained in memory 41. Based on those comparisons, microcomputer 40 controls the impact level provided by the impact generator 71 by controlling solenoid driver 42.
  • Display 50 can also provide treatment information to patient 5.
  • A-to-D convertor 30, microprocessor 40, memory 41, solenoid driver 42, display 50, and patient data module receptacle 53 could be located outside platform 10.
  • This arrangement would be well suited to treatment of different bones - that is, a control system in an enclosure which would be cable connected to an array of different impact-impulse devices designed to treat various bones in the skeletal structure.
  • platform 10 would consist only of solenoid 12, bellcrank 13, impulse translator 14, back rest 15, pad 16, and pivot 17. All the other elements would be located in the control enclosure.
  • Figures 3(a), 3(b), and 4 show, different preload and impactive devices to fit various parts of the body.
  • Preloading can be provided by gravity, mechanical compression devices to simulate gravity, or isometric muscle activity.
  • preloading the legs and spine may be accomplished by having the patient stand in an erect posture on a platform which provides impact through the impulse translator to the os calci as shown in Figure 1.
  • the physician would have a computer system to record the treatment parameters and to read the measured treatment data.
  • Figure 5 shows such a computer system.
  • the doctor's computer system 80 which includes keyboard 81, microprocessor 82, printer 84, modem 85, and patient data module receptacle/writer 86.
  • a physician determines the proper treatment duration, impact load, and impact rate, he causes receptacle/writer 86 to record these values on patient data module 51.
  • patient data module 51 After the patient has undergone treatment and the treatment data has been recorded on patient data module 51, the patient would give module 51 to the physician. The physician would then place data module 51 into receptacle/writer 86 and, microprocessor 82, prints the treatment data using printer 84 or analyzes that data.
  • the treatment data allows the physician to be aware of the patient's compliance as well as the exact dosage received. This kind of monitoring is extremely important in practice. Past exercise systems have had no means to monitor what was being done and relay this information back to the physician, short of direct monitoring by an attendant.
  • Modem 85 provides transmission of patient data to a remote site on a real-time or delayed transmission basis.

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  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Pain & Pain Management (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rehabilitation Therapy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Surgical Instruments (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)

Abstract

On peut traiter les maladies osseuses en appliquant au patient une précharge compressive et une série d'impulsions. Le patient peut être maintenu dans une position statique et la précharge peut être induite par gravité ou compression. La charge et la vitesse des impulsions, et un nombre d'impulsions déterminé par un médecin avant le traitement sont sélectionnés en vue de générer des signaux électriques dans l'os du patient de sorte que la plus grande partie de l'énergie des signaux électriques se situe entre 0,1 Hz et 1 Hz, et que les valeurs d'intensité maximale des signaux électriques se situent entre 15 et 30 Hz.
PCT/US1994/008544 1993-07-02 1994-07-27 Procede et dispositif de traitement des maladies osseuses WO1996003104A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
US08/085,300 US5484388A (en) 1993-07-02 1993-07-02 Method and device for treating bone disorders by applying preload and repetitive impacts
PCT/US1994/008544 WO1996003104A1 (fr) 1993-07-02 1994-07-27 Procede et dispositif de traitement des maladies osseuses
AU75169/94A AU7516994A (en) 1993-07-02 1994-07-27 Method and device for treating bone disorders

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/085,300 US5484388A (en) 1993-07-02 1993-07-02 Method and device for treating bone disorders by applying preload and repetitive impacts
PCT/US1994/008544 WO1996003104A1 (fr) 1993-07-02 1994-07-27 Procede et dispositif de traitement des maladies osseuses

Publications (1)

Publication Number Publication Date
WO1996003104A1 true WO1996003104A1 (fr) 1996-02-08

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Country Status (3)

Country Link
US (1) US5484388A (fr)
AU (1) AU7516994A (fr)
WO (1) WO1996003104A1 (fr)

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WO2006030298A1 (fr) * 2004-09-17 2006-03-23 Giulia Franzoso Appareil de stimulation et methode d'amelioration des performances du systeme neuromusculaire humain
WO2006096734A1 (fr) * 2005-03-07 2006-09-14 Juvent Inc. Système et procédé pour une plaque vibrante à profil bas
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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005115298A1 (fr) * 2004-05-24 2005-12-08 Juvent, Inc. Equipement de mise en position debout assistee a utiliser avec des plaques de mouvement dynamique
JP2008500130A (ja) * 2004-05-24 2008-01-10 ジュベント，インコーポレイテッド 動的運動板を使用した立位補助具
WO2006030298A1 (fr) * 2004-09-17 2006-03-23 Giulia Franzoso Appareil de stimulation et methode d'amelioration des performances du systeme neuromusculaire humain
WO2006096734A1 (fr) * 2005-03-07 2006-09-14 Juvent Inc. Système et procédé pour une plaque vibrante à profil bas
WO2007015856A1 (fr) * 2005-07-27 2007-02-08 Juvent Inc. Appareil de therapie de mouvement dynamique presentant un indicateur de retroaction de traitement
WO2007015749A1 (fr) * 2005-07-27 2007-02-08 Juvent Inc. Procede de controle de l'observation du traitement par le patient au cours d'un traitement par mouvement dynamique
WO2007015748A1 (fr) * 2005-07-27 2007-02-08 Juvent Inc. Appareil de traitement par mouvement dynamique muni d'un indicateur de reaction au traitement
JP2009502320A (ja) * 2005-07-27 2009-01-29 ジュヴェント インコーポレイテッド 動的運動療法中の患者コンプライアンスをモニタする方法及び装置

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US5484388A (en) 1996-01-16

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